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Clinical Trial Report

Gene Therapy Trial Report

Summary

Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy


NCTID NCT06018558 (View at clinicaltrials.gov)
Description
Indication Geographic Atrophy
Compound Name OCU410
Sponsor Ocugen
Funder Type Industry
Status
Recruiting
Enrollment Count 63

Therapy Information


Target Gene/Variant RORA
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Subretinal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV5
Editor Type
Dose 1 2.5 x 10^10 vg/mL
Dose 2 5 x 10^10 vg/mL
Dose 3 1.5 x 10^11 vg/mL
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2023-06-30
Completion Date 2025-09-23
Last Update 2024-10-01

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Eligible Sex ALL

Locations


No.of Trial Sites 9
Locations United States

Regulatory Information


Has US IND True
Recent Updates Dosing of 3rd cohort completed July 2024

Resources/Links